Anal Fistula Plug Versus Endorectal Advancement Flap (AFPERAF)

August 22, 2013 updated by: University of Zurich

An Outcome and Cost Analysis of Anal Fistula Plug Versus Endorectal Advancement Flap in Complex Anal Fistulae

The purpose of this study is to determine whether anal fistula plug or endorectal advancement flap is more successful in the treatment of anal fistulas and compared both procedures with regards to cost.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A detailed analysis will be performed to determine independent predicting factors of recurrence and of higher costs.

Study Type

Interventional

Enrollment (Anticipated)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (18 years of age or more)
  • Single anal fistula
  • Surgically treated with anal fistula plug or endorectal advancement flap

Exclusion Criteria:

  • Children or adolescents
  • Pregnancy
  • Patients treated with setons alone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Recurrent anal fistula
Patients with a complex anal fistula that recurred after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
Procedure: Anal Fistula Plug
Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug
Other Names:
  • Anal Fistula Plug (Cook Medical Inc., Bloomington IL, USA)
Procedure: Endorectal Advancement Flap
Surgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap
Other Names:
  • Advancement Mucosa Flap
Active Comparator: No recurrence of anal fistula
Patients with a complex anal fistula that did not develop recurrence after surgery with an Anal Fistula Plug or and Endorectal Advancement Flap
Procedure: Anal Fistula Plug
Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug
Other Names:
  • Anal Fistula Plug (Cook Medical Inc., Bloomington IL, USA)
Procedure: Endorectal Advancement Flap
Surgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap
Other Names:
  • Advancement Mucosa Flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anal fistula recurrence rate
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost
Time Frame: 3 days
In-hospital costs. Typically 1 to 3 days of hospitalization
3 days
Complication rate
Time Frame: 3 days
Classified according to the Clavien-Dindo Classification of Surgical Complications.
3 days
Length of hospital stay
Time Frame: 3 days
Typically 1 to 3 days of hospitalization.
3 days
Independent factors predicting fistula recurrence
Time Frame: One year
Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management.
One year
Independent factors predicting higher costs
Time Frame: One year
Multivariate analysis of parameters derived from patient demographics and characteristics, surgical procedure, and perioperative management.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Oliver M Fisher, MD, University of Zurich
  • Study Chair: Antonio Nocito, MD, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

August 5, 2013

First Submitted That Met QC Criteria

August 22, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

August 29, 2013

Last Update Submitted That Met QC Criteria

August 22, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFPERAF
  • KEK-ZH-Nr. 2013-XYZ (Other Identifier: Cantonal Ethical Committee Canton of Zurich)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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